Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks (PLUG-I)

PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG-I): Phase 1

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery

Study Overview

• Status: Completed
• Conditions: Postoperative Air Leak
• Intervention / Treatment: Drug: 50 mL of 50% Glucose; Drug: 100 mL of 50% Glucose; Drug: 150 mL of 50% Glucose; Drug: 200 mL of 50% Glucose

Detailed Description

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery (Phase I study). Air leaks from unhealed lung tissue are one of the most common complications after lung surgery including wedge resection, segmentectomy and lobectomy. Air leaks can lead to a delay in chest tube removal, prolonged pain, increased infections, prolonged hospital stay, and increased costs to the health care system. Different agents have been used to heal air leaks by creating a pleurodesis (adhesions to obliterate the pleural space between the visceral and parietal pleura). The success with these agents has been variable and come with the cost of complications that have restricted their use the post-operative period. There has been recent interest in the use of 50% hypertonic glucose (D50) to create pleurodesis with encouraging reports coming mostly from Asia. The investigators have performed a pilot study using 180 mL of D50 instilled through the chest tube for the management of post lobectomy air leak with very encouraging results. This preliminary study used strict inclusion criteria of only lobectomy patients and excluded all patients with known diabetes or any postoperative hyperglycemia. It is unknown if these patients would have benefitted from D50. Also, the optimal dose of D50 was chosen empirically and never clearly defined by previous work. It has been reported that high doses of D50 have been associated with acute lung injury. It is therefore critical that the optimal safe dose is clarified.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years old or older
2. Lung resection is a wedge, segmentectomy, lobectomy or bilobectomy
3. Procedure performed by video-assisted thoracic surgery (VATS) or by Thoracotomy
4. Presence of an air leak on the digital draining system on postoperative day 2

Exclusion Criteria:

1. Large air leak arbitrarily defined as more than 1000 mL/min
2. Allergy to local anesthetics
3. Hemodynamic instability
4. Untreated coronary artery disease
5. Need for respiratory support
6. Any other early post-operative complication
7. Immunity disorder
8. Large pleural fluid output empirically defined as more than 500 mL in the last 12 hours
9. Inability to give consent
10. Fasting glucose ≥ 14 mmol/L the morning of the intervention (arbitrarily chosen cut-off in which patients' diabetes is considered very poorly controlled)
11. Endocrinology service not available to co-manage patients with either diabetes, or a fasting blood glucose ≥ 7 mmol/L, or HbA1c > 6.5%
12. Postoperative evidence of an active thoracic (lung or pleura) infection with systemic inflammatory response syndrome (2 or more of temperature > 38, heart rate > 90, respiratory rate > 20, white blood cell count > 12)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mL Dextrose; 50 mL of 50% dextrose	Drug: 50 mL of 50% Glucose; 1st dose; Other Names: Dextrose
Experimental: 100 mL Dextrose; 100 mL of 50% dextrose	Drug: 100 mL of 50% Glucose; 2nd dose; Other Names: Dextrose
Experimental: 150 mL Dextrose; 150 mL of 50% dextrose	Drug: 150 mL of 50% Glucose; 3rd dose; Other Names: Dextrose
Experimental: 200 mL Dextrose; 200 mL of 50% dextrose	Drug: 200 mL of 50% Glucose; 4th dose; Other Names: Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of treatment related adverse events	occurrence of treatment related adverse events (Grade 3 and more as assessed to the CTCAE v4.0) at any given dose of D50	1 year

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: postoperative; glucose; lung surgery; air leak
• Other Study ID Numbers: PLUG-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No